The use of various indwelling medical catheter tubes, especially feeding tubes, is well known in the medical art. Feeding tubes, such as percutaneous enteral gastrostomy (PEG) tubes or jejunostomy tubes, are used in patients requiring long-term nutritional support. Such tubes may be left within the body for lengthy periods of time, in part, due to their construction of biocompatible materials such as silicone, which material has an ability to remain soft and flexible for long periods of time within the body. In addition, the silicone construction provides for a tube having a smooth surface with a very low coefficient of friction. However, such surface smoothness may have the disadvantage of causing the silicone feeding tube to become very slippery when in contact with body fluids. Thus, the positioning of a tube through an abdominal or gastric wall opening or other body opening is accompanied with the risks of unwanted or accidental slippage of the tube, dislodgement or removal of the tube, or inward migration of the tube into the stomach or other body cavity. It is important that the enteral feeding tube, upon insertion through the body opening or surgically formed feeding stoma, be maintained in a relatively stationary and concentric position during enteral feeding, so as not to cause discomfort or improper delivery of fluids to the patient.
In an attempt to minimize slippage, dislodgement and migration of medical catheters and feeding tubes, others have employed external retention devices. For example, U.S. Pat. No. 4,959,055 to Hillyer discloses a percutaneous tube retainer having an end segment and annular edge which grips the tube outer wall surface to prevent tube slippage. U.S. Pat. No. 5,007,900 to Picha et al., discloses a percutaneous endoscopic gastrostomy device comprising a catheter with a resilient T-bar at one end which bears against the skin of a patient. U.S. Pat. No. 5,092,850 to Buma discloses a catheter with an adjustable external locking bolster similar to a retention disc or bar which can be locked in place to prevent tube slippage. U.S. Pat. No. 4,834,713 to Suthanthiran discloses a catheter button which is inserted into the end of a catheter tube in order to secure the tube.
Although these patents recognize problems associated with securely holding a catheter in place, they have deficiencies. These devices are directed to retention bar devices and devices for insertion into the end of a catheter and do not uniquely fix a catheter or feeding tube in an angular position. Rather, the catheters or feeding tubes of the above discussed patents are typically positioned in an upright or substantially upwardly straight manner, and thus, the tubes may slide through the retention T-bar and further migrate inwardly. In addition, there may be a problem with slippage and migration of the tube in those devices disclosing an end closure of the tube when such end closure is not in use.
U.S. Pat. No. 4,834,712 to Quinn et al., discloses a device for angular fixation of a delivery or drainage tube having sleeve and flange portions. However, the device of Quinn et al., is comprised of two uniquely shaped parts which are difficult to manufacture and high in cost. Furthermore, when in situ, this device is very rigid and is not considered very low profile.
Thus, there is a need for a bumper retention device that holds a catheter or feeding tube securely in place and in an angular fixation, that prevents the tube from slipping through a retention bar, that minimizes removal or dislodgement by a patient, that prevents migration of the tube into the stomach or other body cavity, that causes little, if any, irritation to the skin of a patient, and that is easy to mold, manufacture, assemble, and use.
The present invention overcomes the deficiencies associated with the devices discussed above by providing such a novel bumper retention device having all of the above advantages, and that, in application, can be used with a conventional feeding tube or catheter and a conventional feeding tube retention bar.